FDA approves Dexcom for Bluetooth-enabled CGM G5

By Aditi Pai
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Dexcom G4 System with ShareThe FDA has approved San Diego, California-based Dexcom for a Bluetooth-enabled continuous glucose monitor (CGM), called the G5 Mobile CGM system.

Correction: A previous version of this article incorrectly stated the device had a 510(k) clearance when in fact it had a PMA approval.

Unlike the company's previous connected CGM devices, the G5 Mobile CGM System has Bluetooth built right in to the transmitter and sends glucose data directly to a smartphone, so users don't have to carry a separate receiver device. Data from the CGM can be sent to iOS devices, including the Apple Watch. Dexcom plans to launch an Android version of the app for the CGM early next year.

G5 Mobile CGM users will be able select up to five other people to remotely monitor their glucose information and receive notifications based on that data. This feature is also enabled for Dexcom's other smartphone-connected device, the G4, though that CGM can only send data to a smartphone through Dexcom's Share receiver, which received FDA clearance in January.

The company expects the G5 Mobile system to start shipping in late September. Customers who purchased a G4 Platinum with Share system between August 1 and the G5 Mobile shipment date are able to upgrade their device to the new offering at no extra cost. Dexcom customers using other Dexcom devices that are still under warranty will be able to upgrade to the G5 Mobile system at a lower cost.

“Dexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management," Dexcom CEO Kevin Sayer said in a statement. "Since January, the company has introduced the G4 Platinum CGM with Share, apps to enable the first CGM on the Apple Watch and now the Dexcom G5 Mobile CGM. These advances are making diabetes management more convenient and flexible than ever before. We are excited for the promise this new technology holds for patients and caregivers.”

Sayer explained in a statement that the most recent FDA clearance was granted earlier than expected and financial ramifications like inventory adjustments and revenue recognition policies would be evaluated and discussed in the company's November earnings call.

Recently, on the company's second quarter earnings call, EVP of Strategy and Product Development Steve Pacelli responded to a question about the company’s five-year outlook by describing what a Dexcom CGM might look like in 2020. He explained that five years from now, Dexcom's goal is to have a sensor that would be something that’s miniaturized, looks more like a bandage than a medical device, and is fully disposable.

Less than a week later, news broke that Dexcom partnered with Google Life Sciences to develop the next generation of Dexcom's CGM — a device that is “the size of a dime”, less expensive than current CGMs, and that the companies hope will eventually replace the fingerstick glucometer. The device they are collaborating on is not just for people with Type 1 diabetes but also for those with Type 2 diabetes.